Steady State Bioequivalence Study of Torrent Pharmaceuticals Ltd's Bioequivalence Study of Torrent Pharmaceuticals Ltd's Quetiapine Tablets

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Torrent Pharmaceuticals Limited
ClinicalTrials.gov Identifier:
NCT01634373
First received: June 27, 2012
Last updated: July 2, 2012
Last verified: July 2012
  Purpose

Objective:

Primary objective was to study Steady-state bioequivalence of Torrent's Quetiapine Fumarate Tablets 300 mg.

Study Design:

Randomized, Two-Way, Crossover, multiple Dose, and Open-Label


Condition Intervention Phase
Schizophrenia
Drug: Torrent's Quetiapine Fumarate Tablets
Phase 1

Study Type: Interventional
Official Title: An Open-Label, Randomised, 2-Period, 2-Treatment, 2-sequence, Crossover, Steady State Bioequivalence Study of Quetiapine Fumarate 300 mg Tablets [Test Formulation; Torrent Pharmaceuticals Ltd., India] Versus Seroquel® 300 mg Tablet [Reference Formulation; AstraZeneca, USA] in Schizophrenic Patients.

Resource links provided by NLM:


Further study details as provided by Torrent Pharmaceuticals Limited:

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sex: Male of female
  • Age: 25-65 years
  • Patients who are receiving a stable daily dose of quetiapine 300 mg every 12 hourly for atlist one month
  • Patient willing to adhere to the protocol requirements

Exclusion Criteria:

  • Clinically relevant abnormalities in the results of the laboratory screening evaluation.
  • Clinically significant abnormal ECG.
  • Significant orthostatic hypotension (i.e., a drop in systolic blood pressure of 30 mm Hg or more and/or a drop in diastolic blood pressure of 20 mm Hg or more on standing)
  • Concurrent use of antihypertensive medication or any medication that might pre-dispose to orthostatic hypotension.
  • History of allergic reactions to quetiapine or other chemically related psychotropic drugs.
  • Concurrent primary psychiatric or neurological diagnosis including organic mental disorder, severe tardive dyskinesia, or idiopathic Parkinson's disease.
  • Existence of any surgical or medical condition, which in the judgement of the Principal Investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of patients.
  • Concurrent use of other drugs known to suppress bone marrow function.
  • HIV, HCV, HBsAg positive.
  • Expected changes in concomitant medications during the period of study.
  • A history of epilepsy or risk for seizures
  • positive urine drug of abuse test at enrollment.
  • A history of alcohol or drug dependence by Diagnostic and statistical manual of Mental disorders IV(DSM-IV) criteria during the 6 month period immediately prior to study entry.
  • A total white blood cell count below 4000/ml, or absolute neutrophil count below 2000/ml
  • Female patients with pregnancy or Breast feeding or intend to become pregnant during the study and not able to follow contraception methods.
  • History of multiple syncopal episodes.
  • Administration any study drugs in last 3 months prior to entry in the study.
  • History of significant blood loss due to any reason in the past 3 months.
  • Any pre-existing bleeding disorder.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01634373

Locations
India
Asha Hospital
Hyderabad, India, 500034
Sponsors and Collaborators
Torrent Pharmaceuticals Limited
  More Information

No publications provided

Responsible Party: Torrent Pharmaceuticals Limited
ClinicalTrials.gov Identifier: NCT01634373     History of Changes
Other Study ID Numbers: PK-08-111
Study First Received: June 27, 2012
Last Updated: July 2, 2012
Health Authority: India: Drugs Controller General of India
India: Indian Council of Medical Research

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 24, 2014